CN109200033A - A kind of lidocaine gel emplastrum - Google Patents
A kind of lidocaine gel emplastrum Download PDFInfo
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- CN109200033A CN109200033A CN201811125868.9A CN201811125868A CN109200033A CN 109200033 A CN109200033 A CN 109200033A CN 201811125868 A CN201811125868 A CN 201811125868A CN 109200033 A CN109200033 A CN 109200033A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
A kind of lidocaine gel emplastrum, the gel emplastrum is made of back sheet, drug-reservoir and protective layer, it is characterized in that the drug-reservoir consists of the following components in percentage by weight: the lidocaine 3~6% as active constituent；Oil-phase component 7~12%, the oil-phase component are made of the castor oil and castor oil polyoxyethylene ether of 1:0.2~0.4；Part as water-phase component neutralizes Sodium Polyacrylate 5-10%, glycerine 15-20%, sodium carboxymethylcellulose 1.5~2%, triethyl citrate 0.3%~0.5%, cinnamic acid 0.1%~0.2%, citric acid 0.1%~0.2%, Dihydroxyaluminium Aminoacetate 0.2%~0.4%, mosatil 0.1%~0.3%, the water of filler 1~3% and surplus；It is NP700 that the part, which neutralizes acid polyethylene sodium, and the 30%~50% of the lidocaine is scattered in oily phase, remaining lidocaine is scattered in water phase.
Description
Technical field
The present invention relates to a kind of lidocaine gel emplastrums.
Background technique
Lidocaine (2- (lignocaine)-N- (2,6- 3,5-dimethylphenyl) acetamide, CAS:137-58-6,
Lidocaine, LDC) it is a kind of common local anesthetic, it can be used for topical pain relief.Gel emplastrum (cataplasm,
Cataplasm) have drugloading rate big, drug percutaneous promoted to penetrate, and to skin without allergic reaction and stimulation, when removing without
The advantages that drawing pain and noresidue.Existing lidocaine gel emplastrum product, ((Endo Pharma) at first by remote rattan pharmacy
Listing production, specification are 700mg/13g lotion/140cm2.Its auxiliary material used is Dihydroxyaluminum Aminoacetate (Dihydroxyaluminium Aminoacetate)
EDTA-2Na, glycerol, kaolin, methyl hydroxybenzoate, polyacrylic acid, polyvinyl alcohol, propylene glycol, Nipasol, CMC-Na, polypropylene
Sour sodium, D-sorbite, tartaric acid and urea.But it is found that said preparation is pushed away when foundation from reported pharmacokinetics document
Lidocaine, which only has the 3 ± 2% of dosage, when recommending dosage administration, in LIDODERM to be absorbed.Although the blood in administration
Concentration is lower, but its drug releasing rate is also relatively slow, and throe effect works slower.
Chinese patent CN2010105530468 discloses a kind of external preparation for skin system containing lidocaine or its pharmaceutical salts
Agent, use by lidocaine or its pharmaceutical salts can specificity combination on the anion using water-retaining resin as gel carrier, greatly
The dosage of bulk pharmaceutical chemicals lidocaine or its pharmaceutical salts in preparation when reducing the identical curative effect of acquirement greatly, while reducing the kind of auxiliary material
Class and dosage, simplify operating procedure, reduce production cost.Although however the document is pointed out, the preparation that embodiment provides
Higher Accumulation dissolution is shown in vitro transdermal experiment, but can be seen that from the experimental data that the document provides
Its drug release profiles tends towards stability in end experimental period, illustrates that its drug is comparatively fast being tested early period experimental period in rate of release
The release of latter stage in period is slower.However since there are systemic effects for lidocaine itself, general action effect is in blood concentration
Start to embody when greater than 150ng/mL.And blood concentration is grown simultaneously.But when for local throe, the whole body of lidocaine is made
It with actually a kind of side effect, needs to avoid as far as possible by various technological means, therefore too fast drug releasing rate is practical
Positive influences are had no to therapeutic effect, internal blood concentration excessively high (> 150ng/mL) is will cause instead and is easy to produce systemic
Effect, especially when affected part, area is larger, in the case where needing large area to stick throe.
Chinese document --- the development of lidocaine hydrochloride cataplasm and pharmacokinetic studies (Liu Tingting, the Central China University of Science and Technology
Post-graduate paper, in May, 2007) a kind of cataplasm of lidocaine hydrochloride as active constituent is disclosed, use hydrochloric acid sharp
After more cacaines are as active constituent, although improving the rate of release of main ingredient, blood concentration declines rapidly after reaching peak, biology
Availability is lower than the LIDODERM gel emplastrum as reference agent, while peak blood drug level is also higher, lidocaine blood medicine
The risk that concentration reaches the threshold value for generating systemic reaction is larger.Therefore a kind of novel biological utilisation can be properly increased providing
Degree, and suitable lidocaine can be discharged in the period entirely sticking, keep the gel emplastrum of good analgesic effect to become existing
There is urgent problem to be solved in technology.
Summary of the invention
To solve aforementioned technical problem, the present invention provides a kind of lidocaine gel emplastrum, the gel emplastrum is by carrying on the back
Lining, drug-reservoir and protective layer composition, it is characterized in that the drug-reservoir consists of the following components in percentage by weight: as
The lidocaine 3~6% of active constituent；Oil-phase component 7~12%, the oil-phase component by 1:0.2~0.4 castor oil and castor
Sesame oil polyoxyethylene ether composition；Part as water-phase component neutralizes Sodium Polyacrylate 5-10%, glycerine 15-20%, carboxylic first
Base sodium cellulosate 1.5~2%, triethyl citrate 0.3%~0.5%, cinnamic acid 0.1%~0.2%, citric acid 0.1%~
0.2%, Dihydroxyaluminium Aminoacetate 0.2%~0.4%, mosatil 0.1%~0.3%, the water of filler 1~3% and surplus；The portion
Divide and neutralize acid polyethylene sodium as NP700, the 30%~50% of the lidocaine is scattered in oily phase, the dispersion of remaining lidocaine
In water phase.
A kind of lidocaine gel emplastrum, it is characterized in that the drug-reservoir is by following preferred weight percent
Group is grouped as: the lidocaine 4~5% as active constituent；Oil-phase component 9~11%, the oil-phase component by 1:0.25~
0.35 castor oil and castor oil polyoxyethylene ether composition；As the NP700 7-9% of water-phase component, glycerine 15-20%, carboxylic
Sodium carboxymethylcellulose pyce 1.5~2%, triethyl citrate 0.3%~0.5%, cinnamic acid 0.15%~0.2%, citric acid
0.15%~0.2%, Dihydroxyaluminium Aminoacetate 0.2%~0.4%, mosatil 0.1%~0.3%, filler 1.5~2.5% and remaining
The water of amount；In water-phase component, the 35%~45% of the lidocaine is scattered in oily phase the oil-phase component emulsion dispersion,
Remaining lidocaine is scattered in water phase.The filler is kaolin.The castor oil polyoxyethylene ether is selected from EL-10, EL-
12, EL-20, HEL-20, preferably EL20.
It finds, under the premise of each auxiliary material of preferred gel emplastrum and proportion, disperses part lidocaine under study for action
Oil-phase component, and disperse remaining lidocaine in water-phase component, then oil-phase component emulsion dispersion is formed in hydrogel
Drug-reservoir.Under preferred prescription, obtained lidocaine gel emplastrum both can quickly release the drug to generate analgesic effect,
It can control drug release rate again, by blood concentration control on reduced levels, lidocaine made to play topical pain relief effect
Meanwhile it avoiding blood concentration from being promoted and generating general action.We have further found that, said effect depends on oil simultaneously under study for action
The composition and ratio of phase constituent, the addition and benefit of special ratios triethyl citrate, cinnamic acid and citric acid in water-phase component
Cacaine is scattered in the proportion of water-oil phase.Exactly three matches, and the lidocaine gel emplastrum enable takes into account fast quick-release
Medicine and the performance for stablizing sustained release.We have further found that, change oil-phase component and water-phase component respectively in prescription screening
Component, and change proportion of the lidocaine in water-oil phase, can significantly impact the Release Performance of gel emplastrum.And
Gel emplastrum provided by the invention, transdermal stimulation and sensitivity test prove without apparent skin irritation and sensitization
Property.
Specific embodiment
One of embodiment of the present invention lidocaine gel emplastrum is prepared in accordance with the following methods
1) oil-phase component is prepared, and the raw material of oil-phase component is heated to 50-70 DEG C, lidocaine (LDC) micro mist is added, stirs
It mixes dispersion and obtains oil phase liquid (1)
2) in prescription ratio by mosatil, citric acid and surplus lidocaine micro mist, sodium carboxymethylcellulose, kaolinite
Soil is scattered in suitable water, obtains water phase liquid (2) after mixing evenly；
3) by NP-700, dihydroxy aluminum glycinate, glycerine, obtains liquid (3) after mixing evenly at cinnamic acid mixing；
4) oil phase liquid (1) and water phase liquid (2) are separately heated to 60 DEG C~80 DEG C, under agitation by oil phase liquid (1)
It is slowly added into water phase liquid (2) and obtains lotion, add liquid (3), be sufficiently stirred to obtain drug-reservoir paste, by drug-reservoir
It is coated on the non-woven fabrics of back sheet rapidly, after standing vacuum outgas；Protective layer is attached in upper surface.It is solidifying to obtain lidocaine
Sticker cream.The specification of obtained lidocaine gel emplastrum is 14g drug-reservoir/140cm2Back sheet
In all embodiments and reference examples, it is NP700 (Showa Denko kk production) that part, which neutralizes Sodium Polyacrylate, is filled out
Filling agent is 2% kaolin.
Back sheet is non-woven fabrics, and protective layer is polyethylene (PET) film.
The formula of Examples 1 to 8 see the table below (filler is 2% kaolin, and surplus is water)
Compared with Examples 1 to 9, in the formula of reference examples 1~4 on the basis of the optimal technical scheme of embodiment 8/9, point
It is not added without cinnamic acid, citric acid (reference examples 1), is added without triethyl citrate, cinnamic acid (reference examples 2), is added without lemon
Triethylenetetraminehexaacetic acid ester, citric acid (reference examples 3) and it is added without castor oil polyoxyethylene ether.Reference examples 5/6 then change water phase in oily phase
Lidocaine micro mist proportion.
It is investigated by the gel emplastrum obtained to Examples 1 to 9, it is known that its flat appearance, uniform, drug-reservoir cream
Body is smooth；Mouldability, paste containing amount, initial bonding strength, adhesiveness and film residual quantity meet the requirements.
Pharmacological Examples 1, percutaneous penetration
Method is detailed in the percutaneous dosing novel form in Lu Bin chief editor " novel pharmaceutical formulation and new technology ".Using improvement Franz
Diffusion cell method, using in vitro 3 months old rats skin of abdomen as barrier, the Ba Bu that is prepared with Examples 1 to 6 and reference examples 1~6
Patch carries out carry out in vitro transdermal test.Specific experiment method are as follows:
After taking the anesthesia of 3 monthly age healthy rats to put to death, belly wool is eliminated with scissors, removes undamaged skin, is removed subcutaneous
Tissue is individually fixed in the liberation port of Franz diffusion cell after cleaning, the work release of pH7.4 phosphate buffer is added in receiving chamber and is situated between
Matter keeps endodermis and solution close contact.The gel rubber plaster patch of protective layer, which will be thrown off, makes outer layer jacket on skin, adjusting water-bath
Layer temperature be constant at (37 ± 0.5) DEG C, mixing speed 300rpm, respectively at 0,0.25h, 1h, 2h, 3h, 4h, 6h, 8h, 12h,
For 24 hours, dissolution medium 2ml is drawn, while adding equivalent PBS liquid.Commercially available calculate is taken to add up to absorb percentage (the i.e. accumulative benefit penetrated
More cacaines account for the fractions of lidocaine total amount in drug-reservoir) result such as following table
The above results show lidocaine gel emplastrum provided in an embodiment of the present invention, real carrying out Transdermal Absorption
When testing, accumulative drug transmitance for 24 hours is above reference agent, and the drug release rate in its initial 2h is significantly increased, this
Release is slowly increased increase with time afterwards.And the drug release rate in reference examples in addition to reference examples 5 in initial 2h is lower,
And the drug releasing rate of reference examples 5 is excessively high.Illustrate in the technical solution adopted by the present invention, by preferred oil-phase component respectively with
The composition of water-phase component, had not only properly increased the Transdermal absorption speed of lidocaine gel emplastrum, but also can control drug whole
More uniform slow release, realizes the balance of two kinds of characteristics in a application period.Pass through the control experiment with comparative example
Show to change prescription, or changes the additional amount of lidocaine in grease phase, the lidocaine releasing effect that will affect.
Pharmacological Examples 2, pharmacokinetic studies (rabbit)
Japan large ear rabbit, 2.0 ± 0.2kg of weight are taken, stochastic averagina is grouped, every group of male and female dual-purpose, and every group 8.Administration
The previous day is sloughed the hair of rabbit ridge column two sides with depilatory agent, and depilation area is about 25cm × 15cm, 12h fasting before being administered simultaneously
It can't help water.The dosage of each group is 50mg/kg, and patch point is affixed on ridge column two sides, after administration 15min, 30min, 1,
2, rabbit auricular vein blood 2mL is taken respectively when 3,4,6,8,12, for 24 hours, is detected blood concentration (ng/mL).Data are with mean ± standard
The mode of difference indicates that data are handled using Excel.
Grouping and testing result are following (ng/mL) (n=8, means ± s)
The experimental results showed that lidocaine gel emplastrum provided in an embodiment of the present invention, is giving compared with reference agent
Blood concentration reaches 300ng/mL effect after medicine 1h, but hereafter blood concentration is maintained at and connects in long period (in 12h) holding
In the level of nearly 300ng/mL.The experimental group 2~10 for the gel emplastrum for using each embodiment to obtain is counted on the basis of reference agent
The relative bioavailability of calculation is all larger than 100%, and other than using the experimental group 15 of reference examples 5, using other reference examples
The relative bioavailability of experimental group be respectively less than experimental group 2~10.And in experimental group 15 experimental animal peak plasma concentrations
Be significantly higher than reference agent and other drugs, illustrate its cannot effective Drug controlled release, be easy to produce the whole body of lidocaine
Effect.
Claims (5)
1. a kind of lidocaine gel emplastrum, the gel emplastrum is made of back sheet, drug-reservoir and protective layer, it is characterized in that
The drug-reservoir consists of the following components in percentage by weight: the lidocaine 3~6% as active constituent；Oil-phase component 7
~12%, the oil-phase component is made of the castor oil and castor oil polyoxyethylene ether of 1:0.2~0.4；As water-phase component
Part neutralizes Sodium Polyacrylate 5-10%, glycerine 15-20%, sodium carboxymethylcellulose 1.5~2%, triethyl citrate
0.3%~0.5%, cinnamic acid 0.1%~0.2%, citric acid 0.1%~0.2%, Dihydroxyaluminium Aminoacetate 0.2%~0.4%, edetic acid(EDTA)
Calcium sodium 0.1%~0.3%, the water of filler 1~3% and surplus；It is NP700, the benefit that the part, which neutralizes acid polyethylene sodium,
The 30%~50% of more cacaines is scattered in oily phase, remaining lidocaine is scattered in water phase.
2. a kind of lidocaine gel emplastrum as described in claim 1, it is characterized in that the drug-reservoir is by following weight hundred
The group of ratio is divided to be grouped as: the lidocaine 4%~5% as active constituent；Oil-phase component 9~11%, the oil-phase component by
The castor oil and castor oil polyoxyethylene ether of 1:0.25~0.35 form；As the NP700 7-9% of water-phase component, glycerine
15-20%, sodium carboxymethylcellulose 1.5~2%, triethyl citrate 0.3%~0.5%, cinnamic acid 0.15%~0.2%,
Citric acid 0.15%~0.2%, Dihydroxyaluminium Aminoacetate 0.2%~0.4%, mosatil 0.1%~0.3%, filler 1.5~
2.5% and surplus water；The oil-phase component emulsion dispersion is in water-phase component, 35%~45% dispersion of the lidocaine
In oily phase, remaining lidocaine is scattered in water phase.
3. a kind of lidocaine gel emplastrum as claimed in claim 2, it is characterised in that the filler is kaolin.
4. a kind of lidocaine gel emplastrum as described in claims 1 to 3 is any, it is characterised in that the castor oil polyoxy second
Alkene ether is selected from emulsifier EL 20, emulsifier EL 10, emulsifier EL 12, emulsifier HEL20.
5. a kind of lidocaine gel emplastrum as claimed in claim 4, it is characterised in that the castor oil polyoxyethylene ether
Specification is emulsifier EL -20.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811125868.9A CN109200033A (en) | 2018-09-26 | 2018-09-26 | A kind of lidocaine gel emplastrum |
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| CN201811125868.9A CN109200033A (en) | 2018-09-26 | 2018-09-26 | A kind of lidocaine gel emplastrum |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112220779A (en) * | 2020-11-12 | 2021-01-15 | 浙江鼎泰药业股份有限公司 | Novel transdermal preparation for local analgesia and preparation method thereof |
| WO2022100120A1 (en) * | 2020-11-11 | 2022-05-19 | 长沙晶易医药科技有限公司 | External preparation of lidocaine-prilocaine pharmaceutical composition and application thereof |
| CN115708816A (en) * | 2022-10-20 | 2023-02-24 | 重庆医科大学 | Procaine hydrochloride hydrogel emplastrum and preparation method thereof |
| WO2023035173A1 (en) * | 2021-09-09 | 2023-03-16 | Andros Pharmaceuticals Co., Ltd. | Topical anesthetic agent-clay composite compositions |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5827529A (en) * | 1991-03-30 | 1998-10-27 | Teikoku Seiyaku Kabushiki Kaisha | External preparation for application to the skin containing lidocaine |
| CN107157962A (en) * | 2017-05-16 | 2017-09-15 | 蔡志浩 | flurbiprofen cataplasms |
-
2018
- 2018-09-26 CN CN201811125868.9A patent/CN109200033A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5827529A (en) * | 1991-03-30 | 1998-10-27 | Teikoku Seiyaku Kabushiki Kaisha | External preparation for application to the skin containing lidocaine |
| CN107157962A (en) * | 2017-05-16 | 2017-09-15 | 蔡志浩 | flurbiprofen cataplasms |
Non-Patent Citations (1)
| Title |
|---|
| 刘婷婷;曾凡波;陆喆等: "不同促渗剂对盐酸利多卡因巴布剂透皮的影响", 《中国医院药学杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022100120A1 (en) * | 2020-11-11 | 2022-05-19 | 长沙晶易医药科技有限公司 | External preparation of lidocaine-prilocaine pharmaceutical composition and application thereof |
| CN112220779A (en) * | 2020-11-12 | 2021-01-15 | 浙江鼎泰药业股份有限公司 | Novel transdermal preparation for local analgesia and preparation method thereof |
| WO2023035173A1 (en) * | 2021-09-09 | 2023-03-16 | Andros Pharmaceuticals Co., Ltd. | Topical anesthetic agent-clay composite compositions |
| CN115708816A (en) * | 2022-10-20 | 2023-02-24 | 重庆医科大学 | Procaine hydrochloride hydrogel emplastrum and preparation method thereof |
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Application publication date: 20190115 |